Vaccines, Blood & Biologics
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PROVENGE® (sipuleucel-T)
STN: BL 125197
Proper Name: Autologous Cellular Immunotherapy
Tradename: PROVENGE®
Manufacturer: Dendreon Corporation
Indication:
- For the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
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Supporting Documents
April 29, 2010 Approval Letter - Provenge
Indication: For the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.Summary Basis for Regulatory Action - Provenge, April 29, 2010 (PDF - 169KB)Approval History, Letters, Reviews, and Related Documents - Provenge
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Related Information
Questions and Answers - Provenge FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
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